Trial | NCT02203461  Report issue

Title

Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.
The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD® (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment 3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of insulin resistance, lipid and glucose metabolism will be performed; before and immediately after the treatment. Furthermore, the therapy compliance will be verified using the method of drug counting and therapeutic drug monitoring (TDM).
Study Started
Jul 31
2014
Primary Completion
Oct 31
2014
Study Completion
Oct 31
2014
Last Update
Nov 05
2014
Estimate

Drug Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

STRIBILD® QD, d1-14

  • Other names: STRIBILD®

Drug Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Truvada®/ Kaletra® 200/50 mg QD, d1-14

  • Other names: Truvada® / Kaletra®

Drug Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14

  • Other names: Truvada®/Prezista®/Norvir®

Group I Experimental

STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat

Group II Active Comparator

Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir

Group III Experimental

Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir

Criteria 

Inclusion Criteria:

Healthy male volunteers, age 18-40 years
Informed consent and willingness in study participation
Birth control during study period

Exclusion Criteria:

Participation in other clinical trials
Contraindication or known allergy to study medication
Known metabolic disease incl. Diabetes mellitus, Hypertriglyceridemia or others
Known alcohol or nicotine abuse
HIV infection
History of pharmaceutical study in the last 4 weeks
BMI < 18 > 25
Long-term or regular medication
Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic, psychiatric or metabolic disorder
Dependence to study center or coordinator
Inmates or psychiatric treatment
No Results Posted